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Clinical Trials/NCT04711707
NCT04711707
Unknown
Not Applicable

Addressing the Social Needs of Children Attending a Weight Management Program: a Pilot Randomized Controlled Trial

Hamilton Health Sciences Corporation1 site in 1 country80 target enrollmentJanuary 25, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity, Childhood
Sponsor
Hamilton Health Sciences Corporation
Enrollment
80
Locations
1
Primary Endpoint
Recruitment Rates
Last Updated
5 years ago

Overview

Brief Summary

This study aims to improve the treatment of a common, chronic health concern for children: obesity. It has the potential to improve the care we provide by testing an intervention that addresses social needs and the important upstream factors that influences health outcomes.

Detailed Description

Addressing the social needs of children attending a weight management program. The specific aims of this pilot randomized controlled trial are the following: 1. To determine the feasibility of implementation and delivery of a screening-referral intervention versus usual care to address social needs of children with obesity enrolled in a pediatric weight management program at McMaster Children's Hospital, which will include recruitment rates, uptake of the intervention, and follow-up of participants. 2. To understand impact on health outcomes of a screening-referral intervention versus usual care to address social needs of children with obesity enrolled in a pediatric weight management program including change in i) body mass index z score (zBMI); ii) change in body composition; and iii) change in health-related quality of life. Hypothesis: We hypothesize that health outcomes of children with obesity are connected to the social determinants of health, and that an intervention which screens for and refers to community supports will improve child obesity outcomes.

Registry
clinicaltrials.gov
Start Date
January 25, 2021
End Date
December 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Enrollment in the weight management program

Exclusion Criteria

  • Children in the care of child protection services and/or living in group or foster care. Children in these settings will not be living within typical family-systems to have social needs addressed by this intervention.
  • Parents who cannot read and write in English

Outcomes

Primary Outcomes

Recruitment Rates

Time Frame: 6 months

Recruitment rate refers to the number of participants enrolled and is measured by the number of consent forms signed or implied. Recruitment will be successful if 80% of our target sample is met.

Uptake of Intervention

Time Frame: 6 months

Uptake of the intervention refers to the number of enrolled families who completed all aspect of the intervention. Elements that are part of the uptake include: social history following enrollment as well as the quality of life questionnaires and use of service questionnaire at enrolment and 6-months. Uptake will be considered successful if \>80% of families complete the intervention.

Follow-up of Participants

Time Frame: 6 months

Follow-up of participants refers to the participants attending all of their scheduled study visits. The study will be considered successful if \>90% of participants complete all study visits.

Secondary Outcomes

  • Change in Quality of Life(6 Months)
  • Change in Body Mass Index Z-Score(6 Months)
  • Change in Body Composition(6 Months)

Study Sites (1)

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